Ebony 0.014″ PTA Rx Catheter
Ebony 0.014" PTA Rx Catheter, 2.00 X 200 MM
5manufacturers in China registered for this device type
144catalogue numbers in this listing
9510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Kossel Medtech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Natec Medical Ltd, MU |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2019-07-05 |
| Record revised | 2019-08-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 15 to 40 °C; Special storage condition: keep dry and keep away from sunlight |
| Sizes | Balloon length 10 to 200 mm; balloon diameter 1.5 to 8 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PC048_00-15US | Balloon Length 15 mm | In distribution |
| PC042_00-200US | Balloon Length 200 mm | In distribution |
| PC042_00-150US | Balloon Diameter 2.00 mm | In distribution |
| PC048_00-60US | Balloon Length 60 mm | In distribution |
| PC046_00-10US | Balloon Diameter 6.00 mm | In distribution |
| PC043_00-60US | Balloon Diameter 3.00 mm | In distribution |
| PC042_00-30US | Balloon Length 30 mm | In distribution |
| PC044_00-25US | Balloon Diameter 4.00 mm | In distribution |
| PC044_50-25US | Balloon Length 25 mm | In distribution |
| PC043_50-100US | Balloon Length 100 mm | In distribution |
| PC047_00-100US | Balloon Diameter 7.00 mm | In distribution |
| PC043_00-15US | Balloon Diameter 3.00 mm | In distribution |
| PC045_00-30US | Balloon Diameter 5.00 mm | In distribution |
| PC042_00-60US | Balloon Diameter 2.00 mm | In distribution |
| PC043_50-25US | Balloon Length 25 mm | In distribution |
| PC045_50-25US | Balloon Diameter 5.50 mm | In distribution |
| PC044_00-25USA | Balloon Length 25 mm | In distribution |
| PC042_50-100US | Balloon Length 100 mm | In distribution |
| PC044_00-60US | Balloon Diameter 4.00 mm | In distribution |
| PC046_00-30US | Balloon Diameter 6.00 mm | In distribution |
| PC043_50-200US | Balloon Diameter 3.50 mm | In distribution |
| PC045_00-35US | Balloon Length 35 mm | In distribution |
| PC045_50-40US | Balloon Length 40 mm | In distribution |
| PC045_00-80US | Balloon Diameter 5.00 mm | In distribution |
| PC044_00-35US | Balloon Diameter 4.00 mm | In distribution |
| PC044_50-15US | Balloon Length 15 mm | In distribution |
| PC042_50-120US | Balloon Diameter 2.50 mm | In distribution |
| PC045_00-200US | Balloon Diameter 5.00 mm | In distribution |
| PC042_50-200US | Balloon Diameter 2.50 mm | In distribution |
| PC046_00-80US | Balloon Diameter 6.00 mm | In distribution |
| PC042_50-80US | Balloon Diameter 2.50 mm | In distribution |
| PC045_50-100US | Balloon Diameter 5.50 mm | In distribution |
| PC045_00-20US | Balloon Diameter 5.00 mm | In distribution |
| PC044_00-40US | Balloon Length 40 mm | In distribution |
| PC042_00-35US | Balloon Diameter 2.00 mm | In distribution |
| PC042_50-15US | Balloon Length 15 mm | In distribution |
| PC045_50-150US | Balloon Diameter 5.50 mm | In distribution |
| PC044_50-60US | Balloon Length 60 mm | In distribution |
| PC043_00-25USA | Balloon Length 25 mm | In distribution |
| PC044_00-10US | Balloon Length 10 mm | In distribution |
| PC048_00-40US | Balloon Diameter 8.00 mm | In distribution |
| PC042_00-20US | Balloon Length 20 mm | In distribution |
| PC045_00-60US | Balloon Length 60 mm | In distribution |
| PC045_00-25US | Balloon Length 25 mm | In distribution |
| PC042_00-15US | Balloon Diameter 2.00 mm | In distribution |
| PC047_00-10US | Balloon Length 10 mm | In distribution |
| PC044_50-40US | Balloon Diameter 4.50 mm | In distribution |
| PC043_50-20US | Balloon Diameter 3.50 mm | In distribution |
| PC048_00-20US | Balloon Diameter 8.00 mm | In distribution |
| PC043_50-150US | Balloon Length 150 mm | In distribution |
| PC044_00-150US | Balloon Diameter 4.00 mm | In distribution |
| PC047_00-60US | Balloon Diameter 7.00 mm | In distribution |
| PC046_00-15US | Balloon Length 15 mm | In distribution |
| PC043_50-35US | Balloon Length 35 mm | In distribution |
| PC043_50-10US | Balloon Diameter 3.50 mm | In distribution |
| PC047_00-20US | Balloon Length 20 mm | In distribution |
| PC046_00-35US | Balloon Length 35 mm | In distribution |
| PC043_50-40US | Balloon Diameter 3.50 mm | In distribution |
| PC043_50-60US | Balloon Length 60 mm | In distribution |
| PC047_00-30US | Balloon Length 30 mm | In distribution |
| PC045_00-40US | Balloon Diameter 5.00 mm | In distribution |
| PC045_50-30US | Balloon Length 30 mm | In distribution |
| PC041_50-35US | Balloon Length 35 mm | In distribution |
| PC041_50-30US | Balloon Diameter 1.50 mm | In distribution |
| PC042_00-80US | Balloon Length 80 mm | In distribution |
| PC045_00-100US | Balloon Length 100 mm | In distribution |
| PC044_00-30US | Balloon Length 30 mm | In distribution |
| PC043_00-150US | Balloon Diameter 3.00 mm | In distribution |
| PC042_00-10US | Balloon Length 10 mm | In distribution |
| PC046_00-150US | Balloon Length 150 mm | In distribution |
| PC045_50-10US | Balloon Length 10 mm | In distribution |
| PC046_00-200US | Balloon Diameter 6.00 mm | In distribution |
| PC047_00-35US | Balloon Diameter 7.00 mm | In distribution |
| PC045_50-200US | Balloon Length 200 mm | In distribution |
| PC042_00-40US | Balloon Length 40 mm | In distribution |
| PC044_50-35US | Balloon Length 35 mm | In distribution |
| PC042_50-150US | Balloon Length 150 mm | In distribution |
| PC043_00-35US | Balloon Diameter 3.00 mm | In distribution |
| PC047_00-25US | Balloon Diameter 7.00 mm | In distribution |
| PC042_50-10US | Balloon Diameter 2.50 mm | In distribution |
| PC044_50-80US | Balloon Diameter 4.50 mm | In distribution |
| PC041_50-25US | Balloon Length 25 mm | In distribution |
| PC048_00-25US | Balloon Length 25 mm | In distribution |
| PC042_50-25US | Balloon Length 25 mm | In distribution |
| PC046_00-100US | Balloon Length 100 mm | In distribution |
| PC046_00-25US | Balloon Length 25 mm | In distribution |
| PC046_00-120US | Balloon Diameter 6.00 mm | In distribution |
| PC048_00-35US | Balloon Length 35 mm | In distribution |
| PC045_00-150US | Balloon Length 150 mm | In distribution |
| PC041_50-40US | Balloon Diameter 1.50 mm | In distribution |
| PC048_00-10US | Balloon Diameter 8.00 mm | In distribution |
| PC043_00-80US | Balloon Length 80 mm | In distribution |
| PC044_50-10US | Balloon Diameter 4.50 mm | In distribution |
| PC044_00-100US | Balloon Diameter 4.00 mm | In distribution |
| PC043_00-30US | Balloon Length 30 mm | In distribution |
| PC043_50-80US | Balloon Diameter 3.50 mm | In distribution |
| PC042_50-60US | Balloon Length 60 mm | In distribution |
| PC046_00-40US | Balloon Diameter 6.00 mm | In distribution |
| PC042_50-40US | Balloon Diameter 2.50 mm | In distribution |
| PC045_50-20US | Balloon Length 20 mm | In distribution |
| PC043_00-200US | Balloon Length 200 mm | In distribution |
| PC044_00-80US | Balloon Length 80 mm | In distribution |
| PC044_50-100US | Balloon Length 100 mm | In distribution |
| PC047_00-120US | Balloon Length 120 mm | In distribution |
| PC044_50-20US | Balloon Diameter 4.50 mm | In distribution |
| PC044_50-150US | Balloon Length 150 mm | In distribution |
| PC042_50-35US | Balloon Length 35 mm | In distribution |
| PC043_00-100US | Balloon Diameter 3.00 mm | In distribution |
| PC045_00-15US | Balloon Diameter 5.00 mm | In distribution |
| PC046_00-60US | Balloon Length 60 mm | In distribution |
| PC042_50-30US | Balloon Diameter 2.50 mm | In distribution |
| PC044_50-200US | Balloon Diameter 4.50 mm | In distribution |
| PC043_50-15US | Balloon Length 15 mm | In distribution |
| PC044_50-120US | Balloon Diameter 4.50 mm | In distribution |
| PC042_00-25US | Balloon Diameter 2.00 mm | In distribution |
| PC044_00-15US | Balloon Diameter 4.00 mm | In distribution |
| PC042_00-120US | Balloon Length 120 mm | In distribution |
| PC041_50-20US | Balloon Length 20 mm | In distribution |
| PC043_00-120US | Balloon Length 120 mm | In distribution |
| PC046_00-20US | Balloon Diameter 6.00 mm | In distribution |
| PC048_00-30US | Balloon Diameter 8.00 mm | In distribution |
| PC044_00-120US | Balloon Length 120 mm | In distribution |
| PC045_50-80US | Balloon Length 80 mm | In distribution |
| PC045_50-15US | Balloon Diameter 5.50 mm | In distribution |
| PC043_00-25US | Balloon Diameter 3.00 mm | In distribution |
| PC047_00-15US | Balloon Diameter 7.00 mm | In distribution |
| PC042_50-20US | Balloon Diameter 2.50 mm | In distribution |
| PC047_00-80US | Balloon Length 80 mm | In distribution |
| PC045_50-120US | Balloon Length 120 mm | In distribution |
| PC044_00-20US | Balloon Length 20 mm | In distribution |
| PC043_00-40US | Balloon Length 40 mm | In distribution |
| PC042_00-100US | Balloon Diameter 2.00 mm | In distribution |
| PC045_50-60US | Balloon Diameter 5.50 mm | In distribution |
| PC044_00-200US | Balloon Length 200 mm | In distribution |
| PC045_00-10US | Balloon Length 10 mm | In distribution |
| PC047_00-40US | Balloon Length 40 mm | In distribution |
| PC043_50-30US | Balloon Diameter 3.50 mm | In distribution |
| PC043_00-20US | Balloon Length 20 mm | In distribution |
| PC043_50-120US | Balloon Diameter 3.50 mm | In distribution |
| PC045_50-35US | Balloon Diameter 5.50 mm | In distribution |
| PC044_50-30US | Balloon Diameter 4.50 mm | In distribution |
| PC045_00-120US | Balloon Diameter 5.00 mm | In distribution |
| PC043_00-10US | Balloon Length 10 mm | In distribution |
| PC045_00-25USA | Balloon Length 25 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Parafleet SC 018 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 1,460 |
| Jade Plus PTA Balloon Dilatation Catheter / Jade Plus 18 OTW | OrbusNeich Medical (Shenzhen) Co., Ltd. | 832 |
| Jade PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 667 |
| Parafleet SC 014 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 572 |
| Minerva PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 504 |
| Advocate | Arravasc, Ltd. | 441 |
| Ultraverse® 035 PTA Dilatation Catheter | Bard Peripheral Vascular, Inc. | 361 |
| Polux PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 359 |
| Advance | Cook Incorporated | 355 |
| Pacific™ Plus | Medtronic, Inc. | 347 |
| EverCross™ | ev3, Inc. | 316 |
| Achilles NC PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 297 |
Showing 12 of 167. All products under Catheter, Angioplasty, Peripheral, Transluminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251915 | 2025-12-18 |
| K241040 | 2024-12-18 |
| K220410 | 2022-06-29 |
| K152230 | 2015-09-03 |
| K143041 | 2015-06-04 |
| K143036 | 2015-03-30 |
| K142459 | 2015-02-03 |
| K112513 | 2011-12-09 |
| K103354 | 2011-02-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.